Sept. 8, 2011— -- The makers of the Brazilian Blowout will have to smooth things out with the U.S. Food and Drug Administration if they want to keep selling their hair-straightening products.
In a letter to Mike Brady, chief executive officer of Brazilian Blowout maker GIB LLC, the agency warned that the smoothing solutions sold to salons nationwide contain the potentially dangerous and undisclosed chemical formaldehyde.
"Brazilian Blowout is misbranded because its label and labeling (including instructions for use) makes misleading statements regarding the product's ingredients and fails to reveal material facts with respect to consequences that may result from the use of the product," wrote Michael W. Roosevelt, acting director of the Center for Food Safety and Applied Nutrition's Office of Compliance.
Formaldehyde is a carcinogen, which means it can cause cancer. Brazilian Blowout labels say the products "contain no formaldehyde," as opposed to being "formaldehyde-free," which the labels previously claimed. The products do contain methylene glycol -- a liquid form of the chemical that emits formaldehyde gas when heated.
"The bottom line is that formaldehyde can be released from hair smoothing products that list any of these names on the label and workers can breathe it in or absorb it through their skin," the Occupational Health and Safety Administration warned in April 2011. "Workers can be exposed to formaldehyde during the entire hair straightening process, especially when heat is applied," during blow-drying or flat ironing, for example -- key steps in the blowout process.
But Brady of GIB LLC maintains that the levels of formaldehyde emitted into the air fall well within OSHA's safety limits.
"When you heat up methylene glycol, trace amounts of formaldehyde are released into the air," Brady said. "But OSHA has very clear guidelines on formaldehyde emissions, and our product has never exceeded those guidelines ever."
The Aug. 22 warning letter is the latest wrinkle for Brazilian Blowout (GIB), whose products have prompted a string of lawsuits and hazard alerts.
Brazilian Blowup: Company Battles Class Action Suits
The Brazilian Blowout first came under fire when the Oregon Health and Science University's Center for Research on Occupational and Environmental Toxicology and Oregon OSHA investigated a complaint from a hair stylist who suffered nosebleeds, eye irritation and trouble breathing after using the product. Tests revealed that the product contained up to 10.4 percent formaldehyde -- a chemical name OSHA uses interchangeably with methylene glycol. OSHA requires manufacturers to list formaldehyde on a product's material safety data sheet at levels exceeding 0.1 percent.
The Brazilian Blowout maker GIB fired back with a suit against Oregon OSHA "for damages arising out of misconduct for manipulating test results," in which they claimed methylene glycol was not the same as formaldehyde. But the suit was dropped in March 2011 because "it's very difficult to sue a state agency," Brady said. In the meantime, new lawsuits against the company started piling up.
Most recently, a $5 million lawsuit filed June 27 by stylist Dana Lulgjuraj claims she suffered "physical injuries" while using Brazilian Blowout products at the Butterfly Studio Salon in Manhattan. Brady declined to comment on the case, but said, "Anytime anyone has a negative reaction to a beauty product, it's a shame."
At other salons, stylists and clients wear gas masks to protect themselves.
"We know that lawsuits are pending, and will likely carry on for some time. But now, perhaps, stylists still using the product will finally recognize what the smoothing solution contains, and the importance of preventing exposure," reads a Center for Research on Occupational and Environmental Toxicology statement on the FDA warning letter.
The Brazilian Blowout is one of many keratin-based smoothing treatments hoisted into beauty infamy by stars like Jennifer Aniston and Lindsey Lohan. The treatments range in price from $350 to $600 and promise shiny, frizz-free hair for up to four months.
A class action suit filed in February by San Diego law firm Bonnett, Fairbourn, Friedman and Balint P.C. claims that Brazilian Blowout's false "formaldehyde-free," and "100% salon safe" promises swayed salons into choosing their products over the competition.
"All of GIB's labeling and advertising statements about Brazilian Blowout convey the same message: Brazilian Blowout will safely provide smooth, healthy, frizz-free hair with a smoothing solution containing no harsh chemicals," the lawsuit reads. "There is no other logical reason to purchase Brazilian Blowout and pay the additional price premium over other, less expensive hair smoothing treatments."
The FDA granted GIB LLC 15 business days to respond to the warning and correct the violations, which include selling an adulterated cosmetic and misbranding. Failure to take action, the letter notes, could result in seizure and injunction.